The United States Food & Drug Administration (FDA) has issued a Public Health Advisory of serious, life-threatening adverse effects associated with the psoriasis drug Raptiva (efalizumab). The February 19, 2009 alert has linked the drug to Progressive Multifocal Leukoencephalopathy (PML), a brain infection that can lead to death.
Raptiva efalizumabPsoriasis is a common dermatological condition which manifests itself through painful, raised red patches and itchy spots on the skin. It is caused by a rapid pace of skin cell production triggered by the bodies immune system. While the condition can frequently enter remission, there is no known cure and ultimately returns to an active state.
Raptiva, a prescription drug designed to treat psoriasis, was developed by the pharmaceutical company Genentech. The drug, administered through weekly injections, alleviated the symptoms of psoriasis by suppressing the formation of T cells, a type of white blood cell which causes inflamation of the skin associated with the condition. It is a type of drug commonly refered to as an immuno-suppressant.
After being approved by the FDA in 2003, Raptiva became one of the most widely used forms of treatment for psoriasis.
On October 16, 2008, the FDA issued a “black box warning” to Raptiva which warned patients of the risks of life-threatening infections, including progressive multifocal leukoencephalopathy, also known as PML. Therafter, on February 19, 2009 a Public Healh Advisory was issued by the FDA after receiving confirmed reports of three fatalities in patients using Raptiva who developed PML.
The advisory issued by the FDA strongly recommended that health care professionals carefully monitor all patients on Raptiva, as well as those who have discontinued the drug, for signs of neurologic disease. Furthermore, the Food & Drug Administration also advised that patients on the drug be periodically reassessed to determine whether or not there were benefits to continued treatment in view of identified side effects.
RAPTIVA SIDE EFFECTS
Since entering the market nearly 6 years ago, Raptiva has been found to pose the following potential risks:
- Progressive Multifocal Leukoencephalopathy
- Bacterial Sepsis
- Viral Meningitis
- Invasive Fungal Disease
- Other Opportunistic Infections
- Nervous system disorders
- Thrombocytopenia (low platelet count)
In Europe, regulators have found the risk of side effects so severe that recommendations are being made to the European Commission to completely ban marketing of the product. As stated by the regulators, “prescribers should not issue any new prescriptions for Raptiva and should review the treatment of patients currently receiving the medicine to assess the most appropriate alternatives.” They went on to note that the therapeutic benefit of the drug was ‘modest” and that the benefits of Raptiva ‘no longer outweigh the risks.”
Progressive Multifocal Leukoencephalopathy
PML is caused by a virus that affects the central nervous system. PML usually occurs in people whose immune systems have been severely weakened. Raptiva, by virtue of treating psoriasis by means of its immuno-suppressant properties, contributes to causing this condition. Ultimately, PML leads to an irreversible decline in neurologic function. There is no known treatment which is effective in halting the progressive nature of this condition.
The most common symptoms associated with PML include:
- loss of coordination
- change in vision
- unusual weakness
- difficulty speaking
- personality changes
Side effects of using Raptiva include:
- Chills or fever
- Burning or problems urinating
- Sore throat
Have you suffered Reglan side effects?
If you or a loved one has suffered from an identified Raptiva side effect, you may be eligible to seek compensation for your medical bills, losses and suffering. Please contact us today to speak with a qualified Raptiva attorney at Oshman & Mirisola. We can evaluate your case to determine the best way to protect and maximize your legal interests.